BIMZELX (bimekizumab) Now Approved for Adults with Active Psoriatic Arthritis and for Adults with Axial Spondyloarthritis

2024-03-14

临床结果临床3期上市批准

BIMZELX® (bimekizumab) is the first and only treatment approved by Health Canada for eligible patients with active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) that directly and selectively inhibits two key inflammatory proteins, IL-17A and IL-17F.1 Health Canada's approval is supported by Phase III clinical trial data which found BIMZELX provided significant improvement across key disease severity indicators.2,3,4 The approval of BIMZELX for adults with active PsA or axSpA demonstrates UCB's ongoing commitment to advancing science in immuno-dermatology and rheumatological conditions, addressing unmet patient needs and improving clinical outcomes. OAKVILLE, ON, March 14, 2024 /CNW/ - Today, UCB Canada Inc. is pleased to announce that BIMZELX® (bimekizumab injection) has received authorization from Health Canada for two new indications. On February 23, 2024, BIMZELX was approved for the treatment of adults with active psoriatic arthritis (PsA) and on March 11, 2024, the therapy also received approval for the treatment of adults with axial spondyloarthritis (axSpA). BIMZELX is a monoclonal antibody belonging to a group of medicines called interleukin (IL) inhibitors. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. This medicine works by reducing the activity of two proteins called IL-17A and IL-17F, which are present at increased levels in diseases such as PsA and axSpA.1 BIMZELX is also the first and only biologic that directly inhibits both IL-17A and IL-17F to be approved in Canada. "We are delighted with the approval of BIMZELX in Canada for both psoriatic arthritis and axial spondyloarthritis, and its first marketing authorization for these new indications in North America," said Lionel Houle, Head of Immunology, UCB Canada. "This follows our first product approval in moderate to severe plaque psoriasis. Our sights are set on innovative scientific solutions that can raise the standard of care in the lives of patients. We are proud to bring this new treatment option to people living with these illnesses in Canada, and believe that BIMZELX has the potential to help many patients living with the painful and debilitating symptoms of both conditions." Both Health Canada approvals are based on Phase III data which supports BIMZELX's role as an innovative treatment option for patients with PsA and axSpA, including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS, also known as radiographic axSpA (r-axSpA)).2,3,4 "Psoriatic arthritis is an inflammatory arthritis which affect people with psoriasis. It leads to pain and swelling in the joints, and often results in joint damage, deformities and reduced quality of life and function," explained Dr. Dafna Gladman, Professor of Medicine, University of Toronto and Senior Scientist, Schroeder Arthritis Institute, Krembil Research Institute. "While there are already approved medications for psoriatic arthritis, they do not work for all patients. Bimekizumab is a novel biologic medication which works very well for both psoriasis and psoriatic arthritis. It is exciting for both patients and health care providers that this medication is now added to the current treatment of psoriatic arthritis." "Axial spondyloarthritis is a chronic, painful, inflammatory disease involving the axial skeleton, which significantly impacts patients' mobility, function, and quality of life," said Dr. Proton Rahman, Distinguished Professor, Memorial University and Chief of Rheumatology, Newfoundland and Labrador Health Services. "Primary results from the two Phase 3 studies, BE MOBILE 1 and 2, have convincingly demonstrated that bimekizumab, a novel monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, results in rapid improvement in axial spondyloarthritis symptoms. Bimekizumab marks a significant breakthrough in the management of axial spondyloarthritis and provides hope and relief for many living with this debilitating disease." BIMZLEX was previously approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1 About Psoriatic Arthritis Psoriatic arthritis (PsA) is both an autoimmune disease and a form of inflammatory arthritis. The immune systems of people with PsA attack the joints, in addition to the skin. It is estimated that 0.2 per cent of adults in Canada have PsA, but the exact numbers are unknown. PsA can develop at any age and up to a third (approximately 30 per cent) of people with psoriasis will develop PsA in their lifetime.5 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA) is a chronic, progressive, painful form of inflammatory arthritis that causes significant and long-lasting pain in the lower back, buttocks and hips.6 axSpA can occur at any age, but typically begins between ages 20 and 40.7 Estimates suggest as many as one per cent of the Canadian adult population lives with a form of axSpA known as ankylosing spondylitis (AS).8 BIMZELX Clinical Program Health Canada's approval of BIMZELX for the treatment of adults living with active PsA was based on two multicentre, randomized, double-blind, placebo-controlled studies: BE OPTIMAL: evaluated 852 patients not previously exposed to any biologic disease-modifying anti-rheumatic drug (bDMARD-naïve) for the treatment of psoriasis or PsA2 BE COMPLETE: evaluated 400 patients with an inadequate response or intolerance to treatment with one or two tumour necrosis factor alpha inhibitors (TNFi-IR) for either psoriasis or PsA3 According to the results of both trials, bimekizumab treatment demonstrated positive outcomes at Week 16 vs placebo. The safety pro bimekizumab was consistent with previous Phase III studies in patients with plaque psoriasis, and with IL-17A inhibitors IL-17A inhibitors. In BE OPTIMAL, the most frequent treatment-emergent adverse events (TEAEs) (3 per cent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, upper respiratory tract infection, headache, diarrhoea, oral candidiasis, pharyngitis and hypertension.2 In BE COMPLETE, the most frequent TEAEs (2 per cent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, oral candidiasis and upper respiratory tract infection.3 Health Canada's approval of BIMZELX for the treatment of axSpA was based on two multicentre, randomised, double-blind, placebo-controlled studies: BE MOBILE 1: evaluated 254 patients with non-radiographic axSpA (nr-axSpA) BE MOBILE 2: evaluated 332 patients with ankylosing spondylitis (AS, also known as radiographic axSpA (r-axSpA))4 In both trials, dual inhibition of IL-17A and IL-17F with bimekizumab resulted in improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA. The most frequently reported TEAEs (3 per cent or more in any bimekizumab group in either trial) up to Week 16 were nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis.4 More information about BIMZELX can be found by accessing the product monograph. About UCB Canada Inc. Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult . About UCB UCB, Brussels, Belgium ( ) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. References SOURCE UCB Canada Inc.